FDA 510(k) Application Details - K062604

Device Classification Name	Activated Whole Blood Clotting Time   More FDA Info for this Device
510(K) Number	K062604
Device Name	Activated Whole Blood Clotting Time
Applicant	HAEMOSCOPE CORP. 6231 W. HOWARD ST. NILES, IL 60714 US Other 510(k) Applications for this Company
Contact	ELI COHEN Other 510(k) Applications for this Contact
Regulation Number	864.7140   More FDA Info for this Regulation Number
Classification Product Code	JBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2006
Decision Date	01/31/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review